FDA Approves Pancreatic Enzyme CREON^® as Part of Multi-product Review

May 12, 2009

The U.S. Food and Drug Administration (FDA) has completed approval of CREON^® (pancrelipase), the first pancreatic enzyme replacement therapy to be evaluated and approved under a new drug application (NDA) process for pancreatic enzymes. Pancreatic enzymes help people with cystic fibrosis and other conditions that involve exocrine pancreatic insufficiency to absorb nutrients, including fats, proteins and sugars.

The FDA is requiring all pancreatic enzyme replacement therapies currently on the market to be reformulated and undergo clinical testing in order to receive approval. The Cystic Fibrosis Foundation encouraged the FDA to mandate this NDA process to ensure that all pancreatic enzyme products are of the highest quality. Unapproved products will ultimately be removed from the market, helping to ensure that CF patients receive only products that are documented to be both safe and effective.

Companies currently completing clinical trials for NDA submission to the FDA include Axcan Pharma (Ultrase^®), DCI (PANCRECARB^®), Eurand (Zentase™) and McNeil (Pancrease MT).